Advances in Technology and Their Implications for Global Pharmaceutical Development

6/14/2012

Summary:Advances in Technology and Their Implications for Global Pharmaceutical Development

We are entering one of the most profound periods of human advancement. One that is predicated on the enefits of science and one that can potentially change the nature of human health through direct intervention. Whereas our efforts have previously been to treat illness, our technologies in the near future, by understanding and harnessing human complexity, will also be able to replace and correct what was previously unfixable, and to enhance human performance.

Fundamental to these new approaches is the precise knowledge of the molecular causes of human disease, and the ability to engineer chemical, biological, or mechanical solutions to alter these targets. With the advent of high throughput screening approaches, genomics, informatics, combinatorial chemistry, and automation, the speed of biological discovery has increased by thousands to a million fold. This speed of discovery has had a profound impact on the development of precise diagnostic biomarkers, and in developing new drug therapeutics by the pharmaceutical and biotechnology sectors.

The progress in pharmaceutical is well exemplified in the field of cancer. For example, with the introduction of combination chemotherapy in childhood leukemias, and in testicular cancers in young men, the overall mortality from these cancers has fallen by almost 60%. This has been primarily due to intelligent combinations of chemotherapeutic agents. More recently, however, the focus the pharmaceutical industry in cancer therapeutics has been towards therapeutics specifically targeted at defined molecules as compared to the more indiscriminate approach of inducing DNA damage as had been the case for cytotoxic agents of the past. New drugs synthesized to target one class of enzymes, the kinases, are effective treatments for certain cancers. The introduction of Gleevec as a targeted anti-kinase therapeutic for chronic myelogenous leukemia (CML) has significantly reduced mortality from this disease by almost 50%. In all examples given, these were the first reductions in cancer mortality ever documented on a population scale and are reflected in the significant improvement in national health statistics.

Though prevention and early diagnosis contributed to these improvements in mortality rates, for cancers such as the leukemias and testicular cancers, they are completely attributable to dramatically improved therapies. Thus, dramatic advances in biology and technology have fundamentally changed medicine and the health care landscape mainly in the last twenty-five years.

In the 21st century, some of the changes that have taken place in science and society will significantly alter how the pharmaceutical business will be conducted.

Scientifically, the breakthrough developments are in computational biology, genomics, combinatorial chemistry, and automation. The sequencing of complete genomes including those of humans and important animal models, such as the mouse and the rat, has revolutionized the concept of target identification. In the past, each potential drug target represented by the protein product of a gene was cloned using laborious molecular approaches. The availability of complete genome sequences and full length cDNA (representing the expressed messenger RNA) sequences enables investigators to clone a gene and related molecules with remarkable speed by bypassing physical screening of a genomic library. Advances in combinatorial chemistry provide immense structural diversity for biologists to work with so that millions of unique compounds can be generated and screened rather than only tens of compounds. Structural and computational chemistry has progressed such that any protein target can be virtually assessed for potential chemical inhibitors. Thus, strong candidate drugs can be designed computationally eliminating potentially wasteful wet laboratory experimentation.